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NCT Number: NCT07268885

PRP Spinoplasty for Chronic Low Back Pain With Multiple Pathologies: A Quasi-Experimental Study

This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.

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Key information

Conditions

Lower Back Pain Chronic Back Pain Facet Joint Arthritis Intervertebral disc disease Low Back Pain Lumbar Disc Disease Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allmed Medical Center

Ramallah, Palestinian Territories

About this study

A quasi-experimental study was conducted on 29 patients with chronic LBP who failed conservative therapy. The PRP Spinoplasty protocol involved a single-session, fluoroscopy-guided administration of autologous PRP to the interlaminar epidural space, affected facet joints, and paraspinal muscle trigger points. Outcomes were assessed using the Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), and Single Assessment Numeric Evaluation (SANE) at baseline and at 1 week, 1 month, 3 months, and 6 months post-procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals of both sexes; ages between 18 and 80 years.
  • Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
  • MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
  • Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
  • Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.

Exclusion criteria

  • Presence of local or systemic infection, or fever.
  • Diagnosed with cancer within the past 12 months.
  • Unable to give a consent.
  • History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
  • Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
  • Previous spinal decompression or fusion surgery at the treatment level.
  • Receipt of any spine injection within the previous 12 months.
  • Use of NSAIDs within 2 weeks prior to, or 6 weeks following the procedure.
  • Use of corticosteroids within 6 weeks prior, or after the procedure.
  • Use of anticoagulation or antiplatelet drugs (excluding low-dose Aspirin).
  • History of blood disorders.
  • History of any major surgery within the past 3 months.

Treatment and study plan

Spinoplasty with Platelet Rich Plasma

Biological

The patient received a procedure called "Spinoplasty" which interlaminar epidural, facet joints and trigger point injection with Platelet Rich Plasma (PRP).

Other names: Epidural injection, Facet Joint Injection, Trigger Point Injection

Primary outcomes

  1. Quantifying pain intensity using Numeric Pain Scale (NPS)

    Time frame: 0-6 months

    An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity

  2. Assessing level of functional disability using Oswestry Disability Index (ODI)

    Time frame: 0-6 months

    A 10-item questionnaire assessing the level of functional disability due to low back pain. Scores are calculated from a raw point score of 0-52, with lower scores indicating less disability. The raw score corresponds to the following disability levels: 0-4 points (No disability), 5-14 points (Mild disability), 15-24 points (Moderate disability), 25-34 points (Severe disability), and 35-52 points (Completely disabled)

  3. Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)

    Time frame: 0-6 months

    A patient-reported global assessment score where patients rate their condition on a scale of 0-100%, comparing their current status to their pre-injury baseline

Secondary outcomes

  1. Assessing adverse events from treatment

    Time frame: 0-6 months

    Adverse events were monitored and systematically recorded at each follow-up contact. Patients were asked about any potential complications, including but not limited to severe post-procedural pain, signs of infection (fever, erythema, swelling), new or worsening neurological symptoms, or any other unexpected medical events. we use a checklist of possible complications questionnaire that patients were asked about during follow-ups.

Sponsors and collaborators

Lead sponsor

Allmed Medical Center

Other

Registry information

Official study title

The Efficacy and Safety of Platelet Rich Plasma Spinoplasty in the Management of Lower Back Pain Due to Multiple Pathologies: A Quasi-Experimental Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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